Author: Alison Kneen, Global Market Access Practice Lead

This year has seen more changes in market access than in the last few decades. The market is moving fast, driven by scientific innovation. Patient expectations are continuing to rise; health budgets are feeling the strain of demand, health policy and global politics are taking a leading role with new methodologies, tariffs, and decision-making groups evolving.

We are experiencing unprecedented change, and there is uncertainty as to where the landscape we are moving towards will end.  This is one of the most challenging times to manage pricing or a global launch. Let’s look at several of the key policy changes in 2025 and their immediate relevance.

• In March, we saw the launch of the new EU Joint Clinical Assessment (JCA) with the first twelve assets going through the new process and 50 products planned for assessment in 2026. The introduction of the JCA marks a significant shift towards earlier decision-making and planning for launch preparation within pharmaceutical teams. The JCA drives evidence and access assumptions being visible earlier, with little opportunity to modify once submitted, and it is now critical that in-house teams are aligned and collaborating from phase 1 in the product lifecycle.  It necessitates a reevaluation of launch timelines, pricing, early scenario planning with validation of contingency plans, and evidence generation strategies being incorporated earlier in the product lifecycle.
• There was real movement this year in patient centricity with incorporation of the patient/patient group perspective and corresponding data into product clinical assessments, Health Technology Assessments (HTA), Real-World Evidence (RWE), etc.
• We witnessed a NICE QALY Threshold Increase: The increase in the Quality-of-Life-Adjusted-Years (QALY) threshold by NICE will impact cost-effectiveness evaluations, with the standard threshold rising to £25,000-35,000 per QALY gained. This change is expected to boost NICE reviews to 73-75 drugs/indications per year. Approximately, an extra 4-5 assets are being reviewed per annum and will necessitate modifications of health economic models about to be submitted for assessment.
• The U.S. Most Favored Nation (MFN) Pricing Methodology commenced: The MFN pricing model is reshaping the U.S. drug-pricing landscape and impacting global markets, particularly in Europe. New methodologies are being introduced, e.g., the GENEROUS Model: This new U.S. model introduces international-style reference pricing into Medicaid, emphasizing the need for companies to integrate these benchmarks into their launch planning and global pricing policies.
• We are also witnessing the influence of global politics with a wave of pricing/tariff deals being implemented which is reshaping the U.S. drug-pricing landscape and impacting Europe as tariffs.
• The EU is moving from fragmented national systems toward a more integrated and patient-centered model. We need to be vigilant and understand the market landscape we are working in/launching assets into as many new EU initiatives have sparked into life in response to pricing and reimbursement changes. As an example, to assist addressing MFN pricing policy and managing uncertainty for orphan drugs in assessments, we are seeing new decision/influencer groups, e.g., the Capricord, a group involving clinical experts and patients.

Strategic Implications for 2026 and Beyond

The Evolving Landscape

As the landscape evolves quickly with uncertainty as to where it will end and what it will look like, understanding the impacts is critical as new stakeholders/ decision-makers and influencers evolve, new methodologies and benchmarks are implemented, and budgets are tested even further as patient demand increases. A proactive approach to understanding all aspects of the market access landscape is crucial to enable manufacturers to anticipate payer and decision-maker expectations and align their strategies, accordingly.

Launch Planning and Contracting

With new pricing methodologies and international benchmarking, launch planning/sequencing and contracting strategies must be agile and adaptable. Companies should explore innovative contracting models, scenario plans, and validate to mitigate risks while keeping a watchful eye on the potential impact of new or evolving geopolitics to be ready with their contingencies.

Earlier Decision-Making and Evidence Requirements

The emphasis on earlier evidence-based decision-making will require pharmaceutical specialist teams to collaborate early to ensure alignment with robust HEOR evidence generation; real-world evidence inclusion, where required, and strategic alignment on pricing as submission lockdown of evidence is happening earlier in the process with little opportunity to modify. Manufacturers should prioritize launch planning and validation, remaining flexible to adjust their strategies as affordability becomes even more critical. Manufacturers should consider enhancing value-added programs, e.g., patient support programs, and explore value-based pricing models to ensure access and adherence.

Areas of Tension and Disruption

Geopolitics and the intersection of payer, manufacturer, policymaker, and provider incentives will create areas of tension and potential disruption. Divergent priorities may lead to strategic blind spots, necessitating a comprehensive understanding of stakeholder perspectives and collaborative solutions.

Actionable Takeaways for 2026

To navigate the evolving landscape, manufacturers should consider the following strategic moves:

• Ensure the new evolving market access landscape is understood fully
• Commence Launch Planning and Launch Sequencing early as decision timelines are locking down earlier, e.g., JCA submissions

Reevaluate Pricing Strategies

Align pricing models with new regulatory frameworks and international benchmarks to maintain competitiveness and War Games to test and validate contingency plans.

Enhance Evidence Generation

Prioritize early and initiate comprehensive evidence planning to support not only the regulatory submission, but also the reimbursement submission.

Innovate Contracting Models

Explore value-based and risk-sharing agreements to align with payer expectations and mitigate financial risks.

Strengthen Value-Added Support/Patient Programs

Develop robust patient support initiatives to enhance affordability and adherence, ensuring long-term market success.

In summary, it has been quite a year for market access changes and the most convoluted launch environment I’ve witnessed in nearly forty years working in market access in the life science industry. I have shared a few reflections to be cognizant of and indicated some of the potential impacts. If you require any assistance in understanding the environment changes and potential impact on your asset, please don’t hesitate to reach out to me at marketaccess@biovid.com.